Real World Performance Evaluation of Transcatheter Aortic Valve Implantation

Figure 1. STS Score over time. Scatterplot with interpolation line, demonstrating the reduction of the patient’s risk as defined by STS score over time, from patients 1–910. Individual patients are represented by circles and divided into either a low-intermediate risk group (STS < 8) or high-risk group (STS ≥ 8).

Figure 2. CUSUM Analysis for device success. Incremental line represents unadjusted cumulative sum of failures. Lower and upper limits are calculated upon acceptable and unacceptable failure rates of 5% and 10%, respectively. Observations above the upper limit indicate out of control procedure, while observation below the lower limit suggest better-than-expected results (proficiency). CUSUM analyses are provided for the overall population (A), low-intermediate risk (B), and high-risk subgroups (C).

Figure 3. CUSUM Analysis for early safety. Incremental line represents unadjusted cumulative sum of failures. Lower and upper limits are calculated upon acceptable and unacceptable failure rates of 10 and 20%, respectively. Observations above the upper limit indicate out of control procedure, while observation below the lower limit suggest better-than-expected results (proficiency). CUSUM analyses are provided for the overall population (A), low-intermediate risk (B) and high-risk subgroups (C).

Figure 4. Individual endpoints analysis. Cumulative occurrence of the individual, more clinically relevant VARC-2 endpoints is provided. Vertical dashed bars represent the point at which 50% of each event had occurred.